The TRANSVERSAL Trial: Transvaginal hybrid NOTES versus assisting laparoscopy for sigmoid resection - a randomized controlled trial

The TRANSVERSAL Trial: Transvaginal hybrid NOTES versus assisting laparoscopy for sigmoid resection - a randomized controlled trial - TRANSVERSAL

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005995

Enrollment

Registered

2014-03-27

Start date

2014-11-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K57

Interventions

Group 1: Transvaginal hybrid NOTES sigmoid resection Group 2: Laparoscopic assisted sigmoid resection

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Elective surgical indication for sigmoid resection due to complicated or reoccurring sigmoid diverticulitis classified as IIa, IIb or III according to Hansen and Stock; informed consent;

Exclusion criteria

Exclusion criteria: Age III; Inability to consent; Pregnancy; Genital infection; Neoplasms of vulva, vagina or cervix; Douglas endometriosis; History of pelvic floor repair; Chronic inflammatory bowel disease; Fibromyalgia; Psychiatric disorder; Regular use of analgetics, steroids or anti-depressants;

Design outcomes

Primary

Measure	Time frame
Postoperative pain measured by a Visual Analogue Scale (VAS) after mobilization of the patient 24 hours postoperatively.	—

Secondary

Measure	Time frame
Secondary endpoints: daily pain intensity measured by a Visual Analogue Scale, postoperative mobility measured by a pedometer, operation time, intraoperative complications, number of resected lymph nodes, length of mini-laprotomy, length of the resected specimen, height of the anastomosis, laboratory markers of inflammation (C-reactive protein, leucocytes), use of analgesics, length of hospital stay, time to return to normal activity, morbidity according to Dindo et al., quality of life (Gastrointestinal Quality Of Life Index, GIQLI), sexual function (Female Sexual Function Index, FSFI) and cosmetic satisfaction (body image scale according to Dunker et al.). Secondary outcomes will be assessed during hospital stay and at 3, 12 and 36 months postoperatively	—

Measure

Time frame

Secondary endpoints: daily pain intensity measured by a Visual Analogue Scale, postoperative mobility measured by a pedometer, operation time, intraoperative complications, number of resected lymph nodes, length of mini-laprotomy, length of the resected specimen, height of the anastomosis, laboratory markers of inflammation (C-reactive protein, leucocytes), use of analgesics, length of hospital stay, time to return to normal activity, morbidity according to Dindo et al., quality of life (Gastrointestinal Quality Of Life Index, GIQLI), sexual function (Female Sexual Function Index, FSFI) and cosmetic satisfaction (body image scale according to Dunker et al.). Secondary outcomes will be assessed during hospital stay and at 3, 12 and 36 months postoperatively

—

Countries

Germany, Switzerland

Contacts

Public ContactGeorg Linke

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

georg.linke@med.uni-heidelberg.de06221/568641

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 7, 2026