Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04977882
• Collaborator: (none)
• Enrollment: 75
• Arms: 3
• Anticipated Duration (Months): 17

Study Details

Study Description

Brief Summary

Monocentric pilot prospective randomized study with 3 cohorts: abdominal drainage vs postoperative antibioticoprophylaxis vs none in patients undergoing laparoscopic right hemicolectomy with introcorporeal anastomosis for right colon cancer

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: abdominal drainage; Drug: Postoperative antibiotico-prophylaxis	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abdominal Drainage vs Postoperative Antibiotico-prophylaxis vs Control in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer.
• Anticipated Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abdominal drainage 19 Fr abdominal drainage placed intraoperatevely in right paracolic gutter	Procedure: abdominal drainage; 19 Fr abdominal drainage placed intraoperatively in right colic gutter
Experimental: Postoperative antibiotico-prophylaxis postoperative antibiotico-prophylaxis with Ceftriaxone 2gr and Metronidazole 1.5gr	Drug: Postoperative antibiotico-prophylaxis; Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
No Intervention: Control group No drainage nor postoperative antibiotico-prophylaxis

Outcome Measures

Primary Outcome Measures

1. C-Reactive Proteine [30 days postoperatively]

   measured mg/L in I and III POD

Secondary Outcome Measures

1. White blood cell [30 days postoperatively]

   measured thousands/mL in I and III POD

2. Procalcitonine [30 days postoperatively]

   measured ng/ml in III and V POD

3. Days of hospitalization [90 days postoperatively]

   number of days of hospitalization

4. Readmission rate [90 days postoperatively]

   rate of hospital readmission

5. Mortality rate [90 days postoperatively]

   postoperative mortality

6. Surgical site infection rate [30 days postoperatively]

   postoperative wound infection

7. Anastomotic leak rate [30 days postoperatively]

   postoperative Ileocolic anastomotic leakage

8. Tolerance to liquid diet [30 days postoperatively]

   time to clear fluid tolerance

9. Tolerance to solid diet [30 days postoperatively]

   time to light diet tolerance

10. Time to first flatus [30 days postoperatively]

    Time to first flatus postoperatively

11. Time to first evacuation [30 days postoperatively]

    Time to first evacuation postoperatively

12. need of abdomen CTscan rate [30 days postoperatively]

    need of abdomen CTscan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Right colon cancer

• Intracorporeal anastomosis

• Laparoscopic surgery

• Elective surgery

• informed consent signed

Exclusion Criteria:

• below 18 years old

• IBD

• ASA IV

• T4b

• Metastatic disease

• Preoperative steroids

• Conversion to open surgery

• Emergency surgery

• concomitant major operation

• preoperative infective status

• benign disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Sigismondo Sica, Head of Minimally Invasive Surgery Unit, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT04977882
• Other Study ID Numbers: Registro sperimentazioni XX.21
• First Posted: Jul 27, 2021
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giuseppe Sigismondo Sica, Head of Minimally Invasive Surgery Unit, University of Rome Tor Vergata: intracorporeal anastomosis; right hemicoletomy; colon cancer
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Jul 27, 2021