Condition category
Digestive System
Date applied
29/07/2003
Date assigned
16/10/2003
Last edited
16/05/2011
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

Prof Markus W Büchler

ORCID ID

Contact details

Department of Surgery
University of Heidelberg Medical School
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)622 156 6200
Markus_Buechler@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KSC 01/2003

Study information

Scientific title

Acronym

POVATI-Trial

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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 names

Piritramide

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/10/2003

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant 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

Recruitment start date

01/10/2003

Recruitment end date

01/10/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Surgery
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg Medical School (Germany)

Sponsor details

Department of Surgery
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)622 156 6200
Markus_Buechler@med.uni-heidelberg.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University of Heidelberg Medical School (Germany) - Department of Surgery

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

1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14614782
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19474689
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21559859

Publication citations

  1. Protocol

    Reidel MA, Knaebel HP, Seiler CM, Knauer C, Motsch J, Victor N, Büchler MW, Postsurgical pain outcome of vertical and transverse abdominal incision: design of a randomized controlled equivalence trial [ISRCTN60734227]., BMC Surg, 2003, 3, 9, doi: 10.1186/1471-2482-3-9.

  2. Results

    Seiler CM, Deckert A, Diener MK, Knaebel HP, Weigand MA, Victor N, Büchler MW, Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227)., Ann. Surg., 2009, 249, 6, 913-920, doi: 10.1097/SLA.0b013e3181a77c92.

  3. Results

    Fischer L, Deckert A, Diener MK, Zimmermann JB, Büchler MW, Seiler CM, Ranking of patient and surgeons' perspectives for endpoints in randomized controlled trials--lessons learned from the POVATI trial [ISRCTN 60734227]., Langenbecks Arch Surg, 2011, 396, 7, 1061-1066, doi: 10.1007/s00423-011-0798-3.

Additional files

Editorial Notes