NCT05113134

Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder.

Detailed description

Study design: This was a prospective, single center, single arm study. This clinical trial was approved by the Institutional Review Boards. Study process: All patients gave informed written consent after being informed of the details of the study. All participants underwent demographic and history taking, laboratory tests and a gynecological examination to determine whether specimen removal through vagina is possible. The patients who was adequate for this study were planned to perform multiport laparoscopic surgery and patients were subjected to transvaginal NOSE. To perform transvaginal NOSE procedure, the patients were placed in the lithotomy position with Trendelenburg position. After about 1-2cm incision at the posterior vaginal fornix, endopouch was introduced into the abdominal cavity through vaginal incision site. The specimen was placed inside a endopouch and removed through vagina. Closure of vaginal incision site was achieved by transvaginally with 2/0 absorbable suture. During the second and third visit at 1 week and 8 week, Patient and Observer Scar Assessment Scale (POSAS) was performed to assess cosmetic outcomes of scar. Subjects with sexual activity carried out Female Sexual Function Index (FSFI) questionnaire to assess sexual function at final visit which occurred at 6 months after surgery. Statistical analysis: All data are summarized as means ± standard deviation or as numbers with proportions. A p \< 0.05 was considered to indicate significance. Student's t-test and Mann-Whitney U test were conducted to compare continuous parametric variables and non-parametric variables, respectively.

Conditions

• Colorectal Neoplasms
• Urologic Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms by Site

Interventions

Type	Name	Description
PROCEDURE	Transvaginal natural orifice specimen extraction (NOSE)	Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder will undergo Transvaginal NOSE

Timeline

• Start date: 2015-03-02
• Primary completion: 2020-07-24
• Completion: 2020-07-24
• First posted: 2021-11-09
• Last updated: 2021-11-09