Trial Outcomes & Findings for Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study) (NCT NCT03008707)

NCT ID: NCT03008707

Last Updated: 2019-09-25

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 66 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-09-25

Participant Flow

Participant milestones

Measure	Laparoscopic Peritoneal Lavage Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy Patients who have a laparoscopically approached sigmoidectomy
Overall Study STARTED	28	38
Overall Study COMPLETED	28	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)

Baseline characteristics by cohort

Measure	Laparoscopic Peritoneal Lavage n=28 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy	Total n=66 Participants Total of all reporting groups
Age, Continuous	59.25 years STANDARD_DEVIATION 13.21 • n=93 Participants	55.68 years STANDARD_DEVIATION 10.81 • n=4 Participants	57.19 years STANDARD_DEVIATION 11.92 • n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	26 Participants n=4 Participants	39 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	38 Participants n=4 Participants	66 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Short-term Morbidity	8 Participants	1 Participants

PRIMARY outcome

Timeframe: 30 days

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Short-term Mortality	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 30 days

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Optimal Sepsis Control	19 Participants	37 Participants

PRIMARY outcome

Timeframe: 15 days

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Post-operative Re-interventions Rate	5 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 day

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Mean Postoperative Time	76.74 minutes Standard Deviation 33.18	225.36 minutes Standard Deviation 81.58

SECONDARY outcome

Timeframe: 30 day

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Average Length of Postoperative Hospital Stay	11.4 days Standard Deviation 9.60	8.23 days Standard Deviation 5.21

SECONDARY outcome

Timeframe: 6 months

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Recurrent Colonic Diverticulitis Rate	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Outcome measures

Measure	Laparoscopic Peritoneal Lavage n=27 Participants Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites	Laparoscopically Approached Sigmoidectomy n=38 Participants Patients who have a laparoscopically approached sigmoidectomy
Incisional Hernia Rate	2 Participants	9 Participants

Adverse Events

Laparoscopic Peritoneal Lavage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laparoscopically Approached Sigmoidectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dario Tartaglia

University of Pusa

Phone: +393334491229

Email: dario261184@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place