Trial Outcomes & Findings for Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization (NCT NCT00911989)
NCT ID: NCT00911989
Last Updated: 2012-06-25
Results Overview
The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
Assessed intra-operatively
Results posted on
2012-06-25
Participant Flow
Participant milestones
| Measure |
Transvaginal Sleeve Gastrectomy
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Transvaginal Sleeve Gastrectomy
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
Baseline characteristics by cohort
| Measure |
Transvaginal Sleeve Gastrectomy
n=4 Participants
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
48.3 years
STANDARD_DEVIATION 11.64 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Assessed intra-operativelyPopulation: All subjects on whom the surgery was attempted represent the primary analysis population.
The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.
Outcome measures
| Measure |
Transvaginal Sleeve Gastrectomy
n=4 Participants
All subjects on whom the surgery was attempted.
|
|---|---|
|
Proportion of Procedures Completed With Successful Endoscopic Visualization.
|
4 participants
|
Adverse Events
Transvaginal Sleeve Gastrectomy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transvaginal Sleeve Gastrectomy
n=4 participants at risk
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
|
|---|---|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
Other adverse events
| Measure |
Transvaginal Sleeve Gastrectomy
n=4 participants at risk
Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
|
|---|---|
|
Gastrointestinal disorders
Abnormal faeces
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 4 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Gastrointestinal disorders
Oesophageal pain
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Post procedural complications
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
50.0%
2/4 • Number of events 2 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
75.0%
3/4 • Number of events 4 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
|
Nervous system disorders
Lethargy
|
25.0%
1/4 • Number of events 1 • Adverse events collected from informed consent date to 12 months post surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60