Trial Outcomes & Findings for Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery (NCT NCT01534416)
NCT ID: NCT01534416
Last Updated: 2017-12-20
Results Overview
Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Four hours after conclusion of surgery
Results posted on
2017-12-20
Participant Flow
Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013
Participant milestones
| Measure |
Bupivacaine
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
64
|
|
Overall Study
COMPLETED
|
68
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
Baseline characteristics by cohort
| Measure |
Bupivacaine
n=68 Participants
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=64 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index
|
27.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 6.9 • n=7 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Parity
0
|
21 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Parity
1
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Parity
2
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parity
≥3
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Surgical Indication
Fibroids
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Surgical Indication
Bleeding
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Surgical Indication
Prolapse
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Surgical Indication
Pain
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Surgical Indication
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Surgical Indication
Fibroids & bleeding
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Surgical Indication
Fibroids, bleeding & pain
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Surgical Indication
Bleeding & pain
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Uterine Size
|
13.7 weeks
STANDARD_DEVIATION 5.5 • n=5 Participants
|
14.2 weeks
STANDARD_DEVIATION 4.6 • n=7 Participants
|
14.0 weeks
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Preoperative Hematocrit
|
36.8 % of cells
STANDARD_DEVIATION 4.0 • n=5 Participants
|
36.6 % of cells
STANDARD_DEVIATION 4.2 • n=7 Participants
|
36.7 % of cells
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Admission Planned
|
5 admissions
n=5 Participants
|
1 admissions
n=7 Participants
|
6 admissions
n=5 Participants
|
PRIMARY outcome
Timeframe: Four hours after conclusion of surgeryUnplanned hospital admissions and the hospital admissions at the request of the patients for pain management
Outcome measures
| Measure |
Bupivacaine
n=68 Participants
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=64 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
Saline Group
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
|
Saline Discharged Participants
Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
|
|---|---|---|---|---|
|
Number of Participants With Hospital Admission for Postoperative Pain Control
Unplanned admission
|
23 Participants
|
17 Participants
|
—
|
—
|
|
Number of Participants With Hospital Admission for Postoperative Pain Control
Unplanned admission for pain
|
10 Participants
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1and 2 hour postoperativelyPopulation: This doesn't include hospitalization for reasons other than pain management.
Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.
Outcome measures
| Measure |
Bupivacaine
n=10 Participants
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=40 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
Saline Group
n=11 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
|
Saline Discharged Participants
n=46 Participants
Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
|
|---|---|---|---|---|
|
Postoperative Pain Score
1 hour postoperative
|
4.7 units on a scale
Standard Deviation 2.9
|
3.9 units on a scale
Standard Deviation 2.2
|
5.1 units on a scale
Standard Deviation 2.0
|
4.5 units on a scale
Standard Deviation 2.4
|
|
Postoperative Pain Score
2 hours postoperative
|
4.3 units on a scale
Standard Deviation 2.5
|
2.7 units on a scale
Standard Deviation 1.8
|
4.5 units on a scale
Standard Deviation 2.4
|
3.8 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperativePopulation: Only those subjects with pain analyzed
Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.
Outcome measures
| Measure |
Bupivacaine
n=64 Participants
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=59 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
Saline Group
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
|
Saline Discharged Participants
Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
|
|---|---|---|---|---|
|
Postoperative Pain Score
Day 2 postoperative
|
3.16 units on a scale
Standard Deviation 2.34
|
3.37 units on a scale
Standard Deviation 2.39
|
—
|
—
|
|
Postoperative Pain Score
1 hour postoperative
|
4.30 units on a scale
Standard Deviation 2.55
|
4.69 units on a scale
Standard Deviation 2.29
|
—
|
—
|
|
Postoperative Pain Score
2 hours postoperative
|
3.37 units on a scale
Standard Deviation 2.19
|
4.01 units on a scale
Standard Deviation 2.32
|
—
|
—
|
|
Postoperative Pain Score
4 hours postoperative
|
3.83 units on a scale
Standard Deviation 2.57
|
4.35 units on a scale
Standard Deviation 2.43
|
—
|
—
|
|
Postoperative Pain Score
Day 1 postoperative
|
3.80 units on a scale
Standard Deviation 2.53
|
4.35 units on a scale
Standard Deviation 2.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Postoperative days 0-10Population: missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm
Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.
Outcome measures
| Measure |
Bupivacaine
n=63 Participants
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=60 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
Saline Group
n=63 Participants
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.
|
Saline Discharged Participants
n=60 Participants
Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
|
|---|---|---|---|---|
|
Postoperative Day Pain Medication Use
Postoperative Day 1
|
52 participants
|
52 participants
|
17 participants
|
10 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 2
|
43 participants
|
39 participants
|
24 participants
|
18 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 3
|
28 participants
|
33 participants
|
29 participants
|
22 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 4
|
19 participants
|
26 participants
|
28 participants
|
26 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 5
|
13 participants
|
15 participants
|
19 participants
|
28 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 6
|
12 participants
|
13 participants
|
15 participants
|
24 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 7
|
5 participants
|
11 participants
|
16 participants
|
16 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 8
|
3 participants
|
10 participants
|
12 participants
|
12 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 9
|
2 participants
|
6 participants
|
9 participants
|
11 participants
|
|
Postoperative Day Pain Medication Use
Postoperative Day 10
|
3 participants
|
7 participants
|
9 participants
|
10 participants
|
Adverse Events
Bupivacaine
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine
n=68 participants at risk
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=64 participants at risk
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
|---|---|---|
|
Renal and urinary disorders
Stress Incontinence
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
0.00%
0/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
Other adverse events
| Measure |
Bupivacaine
n=68 participants at risk
Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
|
Saline
n=64 participants at risk
Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
4.7%
3/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Injury, poisoning and procedural complications
Incisional Infection
|
5.9%
4/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
6.2%
4/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Renal and urinary disorders
Urinary Retention
|
8.8%
6/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
9.4%
6/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Injury, poisoning and procedural complications
Small Bowel Mesenteric Hematoma
|
0.00%
0/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
1.6%
1/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
0.00%
0/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Reproductive system and breast disorders
Cervical infection
|
2.9%
2/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
1.6%
1/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Injury, poisoning and procedural complications
Retropubic hematoma
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
1.6%
1/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
Injury, poisoning and procedural complications
Bladder performation
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
0.00%
0/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
General disorders
Seizure
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
0.00%
0/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
|
General disorders
Emergency Room Visit
|
1.5%
1/68 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
0.00%
0/64 • Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, \& radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
|
Additional Information
Dr. Rachel L. Barr Grzesh
Icahn School of Medicine at Mount Sinai
Phone: 212-241-2995
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place