Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

Colorectal Neoplasms Clinical Trial

— STTELS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113134
• Other study ID #: SNUBH B-1411-276-005
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: July 24, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 24, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms
• Neoplasms by Site
• Urologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

References & Publications (3)

Guan X, Liu Z, Longo A, Cai JC, Tzu-Liang Chen W, Chen LC, Chun HK, Manuel da Costa Pereira J, Efetov S, Escalante R, He QS, Hu JH, Kayaalp C, Kim SH, Khan JS, Kuo LJ, Nishimura A, Nogueira F, Okuda J, Saklani A, Shafik AA, Shen MY, Son JT, Song JM, Sun D — View Citation

Park JS, Kang H, Park SY, Kim HJ, Lee IT, Choi GS. Long-term outcomes after Natural Orifice Specimen Extraction versus conventional laparoscopy-assisted surgery for rectal cancer: a matched case-control study. Ann Surg Treat Res. 2018 Jan;94(1):26-35. doi — View Citation

Soyman Z, Kelekci S, Aydogmus S, Demirel E, Ekmekci E. Transabdominal versus transvaginal specimen extraction in mini-laparoscopic surgery. J Obstet Gynaecol Res. 2019 Dec;45(12):2400-2406. doi: 10.1111/jog.14134. Epub 2019 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Observer Scar Assessment Scale (POSAS)	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.	8 week
Secondary	Female Sexual Function Index (FSFI) questionnaire	Sexual function assessment	6 months