Condition category
Digestive System
Date applied
27/12/2007
Date assigned
02/04/2008
Last edited
02/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas D Rink

ORCID ID

Contact details

Clinic of Abdominal and General Surgery
Johannes Gutenberg University
Langenbeckstr. 1
Mainz
55131
Germany
+49 (0)6131 1739 76
andreas.rink@ukmainz.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04004

Study information

Scientific title

Acronym

Study hypothesis

Laparoscopic assisted and facilitated sigmoidectomy result in equivalent postoperative outcomes.

Ethics approval

Ethics Committee of the University of Cologne (ref: 04004)

Study design

Prospective, unblinded, single-centre, randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Cumulative consumption of piritramid administered over 96 hours using a Patient Controlled Analgesia (PCA) protocol

Secondary outcome measures

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 (RenaissanceĀ®, 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.

Overall trial start date

01/06/2004

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Indication for elective sigmoidectomy for diverticulitis

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

50

Participant 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)

Recruitment start date

01/06/2004

Recruitment end date

01/10/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Clinic of Abdominal and General Surgery
Mainz
55131
Germany

Sponsor information

Organisation

Individual Sponsor (Germany)

Sponsor details

Dr. Andreas D. Rink & Prof. Dr. Karl-Heinz-Vestweber
Leverkusen General Hospital
Department of General Surgery
Teaching Hospital of the University of Cologne
Am Gesundheitspark 5
Leverkusen
51375
Germany

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Leverkusen General Hospital, University of Cologne (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes