Combined Medial and Caudal Approach for Right Hemicolectomy
NCT ID: NCT05128708
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2020-08-07
2021-10-01
Brief Summary
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Detailed Description
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Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.
As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:
Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants
All patients with inclusion criteria were subjected to preoperative assessment in the form of:
* Full history.
* Clinical evaluation.
* Laboratory investigation (Complete blood picture, liver function tests, blood sugar, blood urea, serum creatinine, prothrombin time, serum albumin and tumour marker CEA).
* Imaging (chest X-ray, US abdomen, CT abdomen and pelvis).
* Histopathology diagnosis (endoscopic biopsy, tissue diagnosis).
* Determined whether participants underwent open or laparoscopic operation is multifactorial e.g., patients desire, contraindications for laparoscopy and mass size if more than 5 cm preferred to have open surgery.
* Informed written consent taken from the patients or the legal guardian.
operative technique: both groups offered combined medial and caudal approach
* Fasting for 6 hours with no oral intake or only clear fluids intake the day before or better bowel preparation.
* After confirming the availability of blood of matching blood group, general anesthesia is inducted and prophylactic antibiotics are given.
* Patient positioning:
1. group I: (Open cases) The standard position for an open right hemicolectomy is supine with strapping of the ankle and wrists, such as the Trendelenburg position. The surgeon stands on the patient's left, and the first assistant stands across from the surgeon on the patient's right. The scrub nurse stands beside the surgeon. If a second assistant is needed, he or she usually stands across from the surgeon to the left of the first assistant.
2. group II: laparoscopic cases: The patient should be placed in the supine position with his two legs apart and arms tucked beside the body.
The surgeon should stand between the patient's legs with the assistant standing on the patient's left and the camera operator standing on the assistant's left side, and the scrub nurse on the patient's right side.
The video monitor is placed on the patient's upper right.
* Abdominal access and trocar placement by open or closed technique using veress needle for pneumoperitoneum with an intraperitoneal pressure of 14 mmHg.
* The procedure requires 5 trocars.
* A 10 mm trocar is placed 3 cm below umbilicus for the 30° angled telescope to get an adequate view. The incision would be enlarged to extract the specimen and performing anastomosis.
* A12 mm trocar is introduced 5 cm below the telescope port for the surgeon right hand instrument.
* A 5 mm port is inserted at the McBurney's point for the surgeon's left hand instrument.
* Additional two 5 mm trocars are placed at the opposite of McBurney's point and the right subcostal position respectively for the assistant to retract and display the colon and mesocolon.
Intraoperatively, all patients will be assessed for:
* Time of the procedure.
* Amount of blood loss.
post operatively: Postoperative medications given. Monitoring of vital signs and drains. post operative assesment of pain is subjective to the participant as he gave it a score from 1 to 10. minimal pain score(1 to 3), mild (4 to 6) and sever (7 to 10). Ambulation and clear oral fluids started when intestinal sounds are audible followed by soft diet. The intraperitoneal tube drain removed when there is less than 50cc of fluid per 24h or after performing ultrasonography.
Follow up:
Participants are reviewed as outpatients weekly for 1 month or more frequent if they develop any complications between their visits.
The postoperative pathological results, number of lymph node dissection, postoperative exhaust time, postoperative abdominal drain volume and duration, postoperative short term complications, hospital stay and postoperative pathological staging will be recorded.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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open right hemicolectomy
participants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure
combined medial and caudal approach right hemicolectomy open and laparoscopic
resection of right colon cancer by this radical approach
laparoscopic right hemicolectomy
participants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure
combined medial and caudal approach right hemicolectomy open and laparoscopic
resection of right colon cancer by this radical approach
Interventions
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combined medial and caudal approach right hemicolectomy open and laparoscopic
resection of right colon cancer by this radical approach
Eligibility Criteria
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Inclusion Criteria
* No invasion of the surrounding tissue.
* No distant metastasis except the liver.
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Reham Zakaria Mohamed Ahmed
assistant lecturer of general surgery
Principal Investigators
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Reham Z Mohamed, master
Role: PRINCIPAL_INVESTIGATOR
assistant lecturer of general surgery zagazig university
Ali H Elshewy, PhD
Role: STUDY_DIRECTOR
professor of general surgery zagazig university
Abdelrahman A Sarhan, PhD
Role: STUDY_CHAIR
professor of general surgery zagazig university
Gamal M Osman, PhD
Role: STUDY_DIRECTOR
assistant professor of general surgery zagazig university
Locations
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Zagazig University Hospitals
Zagazig, , Egypt
Countries
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References
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Troisi RJ, Freedman AN, Devesa SS. Incidence of colorectal carcinoma in the U.S.: an update of trends by gender, race, age, subsite, and stage, 1975-1994. Cancer. 1999 Apr 15;85(8):1670-6.
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.
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.
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.
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.
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.
Other Identifiers
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zagazig university
Identifier Type: OTHER
Identifier Source: secondary_id
#6199-29-6-2020
Identifier Type: -
Identifier Source: org_study_id