Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen

NCT05113134 | Completed

• 1 other identifier: SNUBH B-1411-276-005
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Neoplasms; Urologic Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site

Keywords

natural orifice specimen extraction; laparoscopic surgery; transvaginal; Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Female Sexual Function Index (FSFI) questionnaire

  6 months

Study Arms (1)

Transvaginal natural orifice specimen extraction (NOSE)

EXPERIMENTAL

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

Procedure: Transvaginal natural orifice specimen extraction (NOSE)

Interventions

Transvaginal natural orifice specimen extraction (NOSE) PROCEDURE

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

Transvaginal natural orifice specimen extraction (NOSE)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Related Publications (4)

• 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.

  PMID: 31580003 RESULT

• 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: 10.4174/astr.2018.94.1.26. Epub 2017 Dec 28.

  PMID: 29333423 RESULT

• 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 DH, Uehara K, Wang GY, Wei Y, Xiong ZG, Yao HL, Yu G, Yu SJ, Zhou HT, Lee SH, Tsarkov PV, Fu CG, Wang XS; International Alliance of NOSES. International consensus on natural orifice specimen extraction surgery (NOSES) for colorectal cancer. Gastroenterol Rep (Oxf). 2019 Feb;7(1):24-31. doi: 10.1093/gastro/goy055. Epub 2019 Jan 23.

  PMID: 30792863 RESULT

• Hwang WY, Suh DH, Lee S. Cosmesis and feasibility of transvaginal natural orifice Specimen extraction (NOSE) for large organ specimen: a prospective pilot study. BMC Urol. 2022 Oct 29;22(1):165. doi: 10.1186/s12894-022-01114-4.

  PMID: 36309743 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Urologic Neoplasms; Gastrointestinal Neoplasms; Neoplasms by Site

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: March 2, 2015
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share