Trial Outcomes & Findings for Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery (NCT NCT01862159)

Results Overview

Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)

Recruitment status

COMPLETED

Target enrollment

25038 participants

Primary outcome timeframe

30 days or the postoperative hospital stay if longer than 30 days

Results posted on

2017-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Operated Patients Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Overall Study STARTED	25038
Overall Study COMPLETED	25038
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Operated Patients n=25038 Participants All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period.
Age, Continuous	41.1 years STANDARD_DEVIATION 10.97 • n=5 Participants
Sex: Female, Male Female	19017 Participants n=5 Participants
Sex: Female, Male Male	6021 Participants n=5 Participants
Region of Enrollment Sweden	25038 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days or the postoperative hospital stay if longer than 30 days

Population: All patients operated after Jan 1, 2010

Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)

Outcome measures

Outcome measures
Measure	Operated Patients n=18737 Participants Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Serious Complications	630 Participants

SECONDARY outcome

Timeframe: operation

length of the operation

Outcome measures

Outcome measures
Measure	Operated Patients n=25038 Participants Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Operating Time	77.2 minutes Standard Deviation 38.10

SECONDARY outcome

Timeframe: 30 days or the postoperative hospital stay if longer than 30 days

Length of stay after the primary operation

Outcome measures

Outcome measures
Measure	Operated Patients n=25038 Participants Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Length of Stay	2.3 days Standard Deviation 3.17

SECONDARY outcome

Timeframe: 30 days or the postoperative hospital stay if longer than 30 days

Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)

Outcome measures

Outcome measures
Measure	Operated Patients n=25038 Participants Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Specific Postoperative Complications	2180 Participants

Adverse Events

Operated Patients

Serious events: 630 serious events

Other events: 2180 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Operated Patients n=25038 participants at risk；n=18737 participants at risk Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Gastrointestinal disorders Serious adverse event	3.4% 630/18737 • Number of events 630

Other adverse events

Other adverse events
Measure	Operated Patients n=25038 participants at risk；n=18737 participants at risk Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery
Gastrointestinal disorders Any postoperative complication	8.7% 2180/25038 • Number of events 2180

Additional Information

Dr Erik Stenberg

Region Örebro län, Sweden AND Örebro University, Sweden

Phone: +46196021000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place