Combined Medial and Caudal Approach for Right Hemicolectomy

NCT05128708 | Completed

• 2 other identifiers: #6199-29-6-2020zagazig university
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.

Conditions

Colon Cancer

Keywords

right colon; medial and caudal approach; hemicolectomy

Outcome Measures

Primary Outcomes (8)

• calculate the duration of operation in both groups

  The duration of operation was calculated in minutes in both groups. group I: open combined medial and caudal right hemicolectomy and group II: laparoscopic combined medial and caudal right hemicolectomy from skin incision till skin closure intraoperatively.

  The duration of operation was calculated intra operatively from skin incision to skin closure. it was ranging from 2 to 4 hours after skin incision.

• Detection of the amount of blood loss during operation in both groups.

  the amount of blood loss during operation is calculated in cubic centimetres using scaled container connected to suction device in both groups.

  the amount of blood loss was detected intra operatively for 4 hours after skin incision.

• Detection of organ or visceral injury in both groups

  detection of organ or visceral injury was done intra operatively by naked eye in both groups.

  detection of organ injury was detected intra operatively for 4 hours after skin incision.

• detection of the duration of hospital stay in both groups

  the duration of hospital stay was detected in days in both groups

  duration of hospital stay was detected from the day of operation till the day of discharge (4 to 7 days postoperatively)

• detection of number of resected lymph nodes in both groups

  the number of resected lymph nodes was detected in post operative histopathological reports in both groups.

  number of resected lymph nodes was detected from 7th to 10th day post operatively

• detection of occurrence of postoperative pain in both groups

  detection of post operative pain was detected in both groups using a written scale fulfilled by the participant giving a score from 1 out of 10 points (1 to 3 points referred as minimal) (4 to 6 points referred as mild) (7 to 10 points referred as sever).

  detection of post operative pain in both groups was done from the day of operation to 7 days postoperatively.

• detection of occurrence fecal fistula in both groups

  occurrence of fecal fistula in both groups was detected by vision of fecal discharge in drains from 48 hours post operatively till discharge day.

  detection of occurrence of fecal fistula in both groups was detected from 2 to 7 days postoperatively

• detection of post operative wound infection in both groups

  post operative wound infection in both groups was detected by vision of wound discharge or pus.

  post operative wound infection in both groups was detected from 2 days to one month post operatively.

Study Arms (2)

open right hemicolectomy

ACTIVE COMPARATOR

participants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure

Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopic

laparoscopic right hemicolectomy

ACTIVE COMPARATOR

participants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure

Procedure: combined medial and caudal approach right hemicolectomy open and laparoscopic

Interventions

combined medial and caudal approach right hemicolectomy open and laparoscopic PROCEDURE

resection of right colon cancer by this radical approach

laparoscopic right hemicolectomy; open right hemicolectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed right colon cancer with colonoscopic biopsy.
• No invasion of the surrounding tissue.
• No distant metastasis except the liver.

You may not qualify if:

• Informed consent refusal
• Malignancy recurrence
• Distant metastasis except the liver.
• Locally advanced tumor.
• participants need emergent intervention e.g., intestinal obstruction or perforation.
• Contraindications specific for laparoscopy for laparoscopy cases

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, 44519, Egypt

Location

Related Publications (6)

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• Gouvas N, Agalianos C, Papaparaskeva K, Perrakis A, Hohenberger W, Xynos E. Surgery along the embryological planes for colon cancer: a systematic review of complete mesocolic excision. Int J Colorectal Dis. 2016 Sep;31(9):1577-94. doi: 10.1007/s00384-016-2626-2. Epub 2016 Jul 28.

  PMID: 27469525 BACKGROUND

• Jessup JM, McGinnis LS, Steele GD Jr, Menck HR, Winchester DP. The National Cancer Data Base. Report on colon cancer. Cancer. 1996 Aug 15;78(4):918-26. doi: 10.1002/(SICI)1097-0142(19960815)78:43.0.CO;2-W.

  PMID: 8756390 BACKGROUND

• Chen Q, Shuai X, Chen L. [Safety and feasibility of the combined medial and caudal approach in laparoscopic D3 lymphadenectomy plus complete mesocolic excision for right hemicolectomy in the treatment of right hemicolon cancer complicated with incomplete ileus]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Sep 25;21(9):1039-1044. Chinese.

  PMID: 30269325 BACKGROUND

• Li F, Zhou X, Wang B, Guo L, Wang J, Wang W, Fu W. Comparison between different approaches applied in laparoscopic right hemi-colectomy: A systematic review and network meta-analysis. Int J Surg. 2017 Dec;48:74-82. doi: 10.1016/j.ijsu.2017.10.029. Epub 2017 Oct 12.

  PMID: 29032159 BACKGROUND

• Xie D, Yu C, Gao C, Osaiweran H, Hu J, Gong J. An Optimal Approach for Laparoscopic D3 Lymphadenectomy Plus Complete Mesocolic Excision (D3+CME) for Right-Sided Colon Cancer. Ann Surg Oncol. 2017 May;24(5):1312-1313. doi: 10.1245/s10434-016-5722-1. Epub 2016 Dec 19.

  PMID: 27995452 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Reham Z Mohamed, master

  assistant lecturer of general surgery zagazig university

  PRINCIPAL INVESTIGATOR

• Ali H Elshewy, PhD

  professor of general surgery zagazig university

  STUDY DIRECTOR

• Abdelrahman A Sarhan, PhD

  professor of general surgery zagazig university

  STUDY CHAIR

• Gamal M Osman, PhD

  assistant professor of general surgery zagazig university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of general surgery

Model Details: all participants underwent right hemicolectomy using combined medial and caudal approach and divided into 2 groups group I had open surgery and group II had laparoscopic surgery

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 22, 2021
• Study Start: August 7, 2020
• Primary Completion: August 28, 2021
• Study Completion: October 1, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)