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Table 1 Eligibility Criteria

From: Totally laparoscopic versus conventional ileoanal pouch procedure – design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy- LapConPouch-Trial

Inclusion Criteria

At study enrolment

• Age equal or greater than 14 years (providing informed consent by patient and by parents or legal guardian between 16–18, only patient when 18 or older)

• Patients with benign disease (familial polyposis or ulcerative colitis) scheduled for elective surgery

• Patient or guardian has given informed consent

• Both standardised surgical approaches are suitable for treatment

At the end of surgical exploration

• Suitable for restorative proctocolectomy

Exclusion Criteria

• Active malignant disease or high suspicion for malignancy (clinical and imaging evidence, e.g. higher grade dysplasia on histology) *

• Previous median laparotomy or Pfannenstiel incision (excluding limited incision such as appendectomy, cholecystectomy etc.)

• Participation in another intervention-trial with interference of intervention and outcome

• Severe psychiatric or neurologic diseases

• Drug- and/or alcohol-abuse according to local standards

• Coagulopathy

  1. * modified to patients with non-advanced tumors (≤T2), see subheading ethics and informed consent