Laparoscopic-assisted or -facilitated sigmoidectomy for diverticulitis? A prospective randomised trial

ISRCTN	ISRCTN23817011
DOI	https://doi.org/10.1186/ISRCTN23817011
Protocol serial number	04004
Sponsor	Individual Sponsor (Germany)
Funder	Leverkusen General Hospital, University of Cologne (Germany)

Submission date: 27/12/2007
Registration date: 02/04/2008
Last edited: 02/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andreas D Rink
Scientific

Clinic of Abdominal and General Surgery
Johannes Gutenberg University
Langenbeckstr. 1
Mainz
55131
Germany

Phone	+49 (0)6131 1739 76
Email	andreas.rink@ukmainz.de

Study information

Primary study design	Interventional
Study design	Prospective, unblinded, single-centre, randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Laparoscopic assisted and facilitated sigmoidectomy result in equivalent postoperative outcomes.
Ethics approval(s)	Ethics Committee of the University of Cologne (ref: 04004)
Health condition(s) or problem(s) studied	Diverticulitis of the sigmoid colon
Intervention	Group 1: Laparoscopic assisted sigmoidectomy with extraction of the specimen via a 5 cm mini-incision in the lower left abdomen Group 2: Laparoscopic facilitated sigmoidectomy with laparoscopic mobilisation of the sigmoid colon and conventional resection and anastomosis via a 10-12 cm transverse suprapubic incision
Intervention type	Other
Primary outcome measure(s)	Cumulative consumption of piritramid administered over 96 hours using a Patient Controlled Analgesia (PCA) protocol
Key secondary outcome measure(s)	1. The course of postoperative analgesic consumption over 7 days. 2. Amount of postoperative pain and fatigue. Pain was evaluated daily using a visual analogue scale. It was documented once daily starting on the day prior to surgery and then in the morning of each postoperative day. Fatigue was also measured using a visual analogue scale. Fatigue was measured preoperatively and on days 3, 5, 7, 21 and 42 after surgery. 3. Resumption of bowel activity - the time-point of first passage of flatus and the first passage of stool were documented. 4. Pulmonary function, assessed by measuring Forced Vital Capacity (FVC) and forced expiratory volume in 1 second (FEV1) with a mobile spirometer (Renaissance®, Nellcor Puritan Bennett). Pulmonary function was measured the day before surgery and on days 2, 3, 5, and 7. The postoperative data on pulmonary function for each patient were calculated in relation to the preoperative values. 5. Quality of life, measured using the Gastrointestinal Quality of Life Index. It was determined preoperatively, and on days 7, 21, 42 and after one year after surgery. 6. Satisfaction with the cosmetic result, evaluated using the Body Image Questionnaire. The evaluation was performed at one year after surgery.
Completion date	01/10/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	50
Key inclusion criteria	Indication for elective sigmoidectomy for diverticulitis
Key exclusion criteria	1. Proven or suspected malignancy 2. Prior major abdominal surgery performed through a midline incision 3. Diverticulitis in association with fistula and abscesses (if diagnosed preoperatively)
Date of first enrolment	01/06/2004
Date of final enrolment	01/10/2005

Locations

Countries of recruitment

Germany

Study participating centre

Clinic of Abdominal and General Surgery

Mainz
55131
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan