Natural Orifice Specimen Extraction Surgery for Colorectal Cancer

NCT05740267 | Unknown

• 1 other identifier: 202102468A3
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this type of study: a prospective, randomized controlled clinical trial is to assess the safety and feasibility of NOSE surgery to compare the NOSE and conventional laparoscopy groups in Colorectal cancer patients. The main questions it aims to answer are measuring the postoperative inflammatory response and monitoring the early morbidity and mortality rate after surgery. Participants will be assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection. If there is a comparison group: Researchers will compare the control group to see if postoperative inflammatory response.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• C-reactive protein (CRP) level

  The primary outcome measure was the postoperative inflammatory response, which was evaluated by monitoring the C-reactive protein (CRP) level during hospitalization on the 3rd day following surgery. Complete blood cell count and differential count, C-reactive protein, procalcitonin, and interleukin-6 will be measured on day 3 postoperatively

  3 minutes

Secondary Outcomes (5)

• Duration of Operation time

  60~90 minutes

• Peritoneal Cytology during surgery

  3 minutes

• Peritoneal Contamination during surgery

  3 minutes

• Postoperative Pain Score

  3 minutes

• Postoperative Recovery course:

  1 to 5 days

Study Arms (2)

Conventional laparoscopy group

NO INTERVENTION

The investigators can select either the intracorporeal or extracorporeal method to create bowel anastomoses. For the extracorporeal way, a mini-laparotomy wound is created and exteriorizes the bowel to do the anastomosis. The specimen is removed via the mini-laparotomy wound after the anastomosis is accomplished for the intracorporeal approach.

NOSE group

EXPERIMENTAL

After bowel resection, all bowel anastomoses are created via side-to-side intracorporeal anastomosis, either isoperistaltic or antiperistaltic. The surgical steps of NOSE with the transrectal method are illustrated in Figure 1. First, the rectosigmoid colonic lumen is blocked with a bowel clamp. After rectal irrigation with povidone-iodine water, a transanal endoscopic microsurgery (TEM) scope or Alexis wound protector is inserted through the anus, reaching the upper rectum. Enterotomy is performed at the upper rectum, and a suction device is used to clean any fecal spillage. The TEM scope is pushed forward beyond the rectal opening, and the specimen is extracted with the TEM scope. The rectal opening is closed with a barbed suture, and an air leak test is performed to identify anastomotic leakage.

Procedure: Natural Orifice Specimen Extraction

Interventions

Natural Orifice Specimen Extraction PROCEDURE

After bowel resection, all bowel anastomoses are created via side-to-side intracorporeal anastomosis, either isoperistaltic or antiperistaltic. The surgical steps of NOSE with the transrectal method are illustrated in Figure 1. First, the rectosigmoid colonic lumen is blocked with a bowel clamp. After rectal irrigation with povidone-iodine water, a transanal endoscopic microsurgery (TEM) scope or Alexis wound protector is inserted through the anus, reaching the upper rectum. Enterotomy is performed at the upper rectum, and a suction device is used to clean any fecal spillage. The TEM scope is pushed forward beyond the rectal opening, and the specimen is extracted with the TEM scope. The rectal opening is closed with a barbed suture, and an air leak test is performed to identify anastomotic leakage.

NOSE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Performance status of 0 - 2 on the ECOG (Eastern Cooperative Oncology Group) scale
• American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
• Tumor location: CRC with the lower margin of the tumor greater than 10 cm from the anal verge
• Pre-operative T staging: T0-T4a at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
• Preoperative M staging: M0 according to AJCC 8th
• Tumor size: 4 cm or less
• Written informed consent for participation

You may not qualify if:

• Not suitable for minimally invasive surgery
• Body mass index (BMI) \>30 kg/m2
• Malnutrition: albumin level less than 3.5
• Previous pelvic surgery
• Emergency surgery

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (22)

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• Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.

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• Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

  PMID: 30426190 BACKGROUND

• Saad S, Hosogi H. Natural orifice specimen extraction for avoiding laparotomy in laparoscopic left colon resections: a new approach using the McCartney tube and the tilt top anvil technique. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):689-92. doi: 10.1089/lap.2010.0303.

  PMID: 20874237 BACKGROUND

• Wolthuis AM, de Buck van Overstraeten A, Fieuws S, Boon K, D'Hoore A. Standardized laparoscopic NOSE-colectomy is feasible with low morbidity. Surg Endosc. 2015 May;29(5):1167-73. doi: 10.1007/s00464-014-3784-3. Epub 2014 Aug 23.

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• Park JS, Choi GS, Kim HJ, Park SY, Jun SH. Natural orifice specimen extraction versus conventional laparoscopically assisted right hemicolectomy. Br J Surg. 2011 May;98(5):710-5. doi: 10.1002/bjs.7419. Epub 2011 Feb 8.

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• Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.

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• Senft JD, Droscher T, Gath P, Muller PC, Billeter A, Muller-Stich BP, Linke GR. Inflammatory response and peritoneal contamination after transrectal natural orifice specimen extraction (NOSE) versus mini-laparotomy: a porcine in vivo study. Surg Endosc. 2018 Mar;32(3):1336-1343. doi: 10.1007/s00464-017-5811-7. Epub 2017 Aug 25.

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• Cheng CC, Hsu YR, Chern YJ, Tsai WS, Hung HY, Liao CK, Chiang JM, Hsieh PS, You JF. Minimally invasive right colectomy with transrectal natural orifice extraction: could this be the next step forward? Tech Coloproctol. 2020 Nov;24(11):1197-1205. doi: 10.1007/s10151-020-02282-x. Epub 2020 Jul 6.

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• Jong BK, Cheng CC, Hsu YJ, Chern YJ, Tsai WS, Hung HY, Liao CK, Yeh CY, Hsieh PS, You JF. Transrectal natural orifice specimen extraction in left hemicolectomy for tumours around the splenic flexure: Old wine in new bottles. Colorectal Dis. 2022 Jan;24(1):128-132. doi: 10.1111/codi.15930. Epub 2021 Oct 10.

  PMID: 34601777 BACKGROUND

• Zhou ZQ, Wang K, Du T, Gao W, Zhu Z, Jiang Q, Ji F, Fu CG. Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial. J Surg Res. 2020 Oct;254:16-22. doi: 10.1016/j.jss.2020.03.064. Epub 2020 May 8.

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• Muller PC, Dube A, Steinemann DC, Senft JD, Gehrig T, Benner L, Nickel F, Muller-Stich BP, Linke GR. Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial. J Surg Res. 2018 Dec;232:635-642. doi: 10.1016/j.jss.2018.07.066. Epub 2018 Aug 16.

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• Homma Y, Hamano T, Akazawa Y, Otsuki Y, Shimizu S, Kobayashi H, Kameoka S, Kobayashi Y. Positive peritoneal washing cytology is a potential risk factor for the recurrence of curatively resected colorectal cancer. Surg Today. 2014 Jun;44(6):1084-9. doi: 10.1007/s00595-013-0689-z. Epub 2013 Aug 14.

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  PMID: 31401769 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Lo AL, Hsu YJ, Chern YJ, Cheng CC, Jong BK, Yu ZH, Chan LY, You JF; NOSE study group of Taiwan Colorectal Action Research Society. Mini-laparotomy versus transrectal natural orifice specimen extraction for minimally invasive colorectal cancer surgery: study protocol for a randomized controlled trial (MINITR-NOSE trial, TCAR2514 protocol). Trials. 2025 Aug 25;26(1):304. doi: 10.1186/s13063-025-09039-7.

  PMID: 40855494 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jeng-Fu You

  Principal Investigator

  STUDY DIRECTOR

Central Study Contacts

Jeng-Fu You

CONTACT

+886-3-3281200; jenodyssey@gmail.com

Yih-Jong Chern

CONTACT

+886-3-3281200; ufo789.ufo789@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization assignment is performed by the statisticians of the clinical trial center to generate random codes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be performed in the operating room at the Colorectal division, Linkou Chang Gung Memorial Hospital. Following the induction of minimally invasive surgery, an independent research assistant randomly assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection by sealed-envelope randomization.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 23, 2023
• Study Start: March 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 23, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share