Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

Not Applicable

Completed

• Conditions: Urologic Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site; Colorectal Neoplasms
• Interventions: Procedure: Transvaginal natural orifice specimen extraction (NOSE)

• Registration Number: NCT05113134
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Study Timeline

• Study Start: 2015-03-02
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Status Verified: 2021-10
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Patients who are accessible with vaginal approach
• Patients scheduled for laparoscopic resection of stomach, colon, kidney and spleen for benign or malignant diseases
• Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings

Exclusion Criteria

• Patients without sexual intercourse
• Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination
• Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history
• Patients with abnormal cervical cancer screening tests
• Patients scheduled to perform concomitant hysterectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal natural orifice specimen extraction (NOSE)	Transvaginal natural orifice specimen extraction (NOSE)	The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder

Primary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS)	8 week	Cosmetic outcomes of scar assessed by Patient and Observer Scar Assessment Scale (POSAS) 1 week and 8 weeks after surgery. The POSAS is the international validated scar assessment questionnaire that measures quality of the scar from the perspective of both patient and observer.

Secondary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI) questionnaire	6 months	Sexual function assessment