Postsurgical pain Outcome of Vertical And Transverse abdominal Incision: a randomised controlled equivalent Trial

ISRCTN	ISRCTN60734227
DOI	https://doi.org/10.1186/ISRCTN60734227
Protocol serial number	KSC 01/2003
Sponsor	University of Heidelberg Medical School (Germany)
Funder	University of Heidelberg Medical School (Germany) - Department of Surgery

Submission date: 29/07/2003
Registration date: 16/10/2003
Last edited: 16/05/2011

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Markus W Büchler
Scientific

Department of Surgery
University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone	+49 (0)622 156 6200
Email	Markus_Buechler@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	POVATI-Trial
Study objectives	Patients with intra-abdominal pathologic diseases, certainly operable throughout both approaches such as: stomach, pancreas and small or large bowel. This is a randomized controlled observer and patient-blinded two-group parallel trial to answer the question if the transverse abdominal incision is equivalent to the vertical one due to the described endpoints.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Abdominal surgery
Intervention	After randomisation either in the transverse or in the vertical (= midline) group a standardised surgical abdominal approach is performed. Further surgical procedure in the vertical as well in the transverse group follows given prespecified standards. Patients are blinded via a special wound dressing. Outcome assessors are unaware of the intervention.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Piritramide
Primary outcome measure(s)	The primary endpoint is the abdominal pain intensity experienced by a patient, quantified with the Visual Analogue Scale (VAS), and the amount of analgesic required (piritramide [mg/h]) on the second postoperative day.
Key secondary outcome measure(s)	Secondary objectives are the frequencies of early- and late-onset complications such as burst abdomen, postoperative pulmonary complications, wound infections and incisional hernias. In addition, pain is quantified according to the Pain-Sensation-Scale by Geissner, a modified McGill Pain Questionnaire, designed for studies conducted in Germany.
Completion date	01/10/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	172
Key inclusion criteria	Hospitalised patients of the Department of General-, Visceral-, Traumasurgery and Outpatient Clinic of the University of Heidelberg, Medical School, who are planned for an elective abdominal operation and are suitable for both transverse and vertical incision. 1. Age equal or greater than 18 years 2. Expected survival time more than 12 months 3. Patients scheduled for the following procedures: a) Whipple procedure (classic or pylorus-preserving) b) Duodenum-preserving resection of the pancreatic head c) Gastrectomy (partial or total gastrectomy) d) Colon resection (left or right or transverse / classic or extended) e) Ileocecal resection 4. Primary and elective laparotomy 5. Patient must be able to give informed consent 6. Patient has given informed consent
Key exclusion criteria	1. Permanent therapy with a opioid equivalent drug for any reason within 12 months before operation (duration longer than 2 weeks) 2. Incompatibility of metamizole 3. Recurrent opening of the abdominal cavity (not laparoscopic appendectomy, laparoscopic cholecystectomy, laparoscopic adrenalectomy, diagnostic laparoscopy or appendectomy), including prior cesarean section and Pfannenstiel incision (e.g., hysterectomy) 4. Participation in another intervention trial that would interfere with the intervention and outcome of this study 5. Severe psychiatric or neurologic diseases 6. Lack of compliance 7. Drug and/or alcohol abuse according to local standards 8. Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprine) 9. Chemotherapy within 2 weeks before operation 10. Radiotherapy of the abdomen completed longer than 8 weeks before operation (except for neoadjuvant therapy, e.g. for pancreatic cancer) 11. Liver, gallbladder, spleen, and rectum surgery
Date of first enrolment	01/10/2003
Date of final enrolment	01/10/2004

Locations

Countries of recruitment

Germany

Study participating centre

Department of Surgery

Heidelberg
69120
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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009	Yes	No
Results article	results	01/10/2011	Yes	No
Protocol article	protocol	13/11/2003	Yes	No