Evidence map›Paper›PMID 38970713›Full record

Trial reportInternational journal of colorectal disease2024

Gastrointestinal functions after laparoscopic right colectomy with intracorporeal anastomosis: a pilot randomized clinical trial on effects of abdominal drain, prolonged antibiotic prophylaxis, and D3 lymphadenectomy with complete mesocolic excision.

Giuseppe S Sica, Leandro Siragusa, Brunella Maria Pirozzi, Roberto Sorge, Giorgia Baldini, Cristina Fiorani, Andrea Martina Guida, Vittoria Bellato, Marzia Franceschilli

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04977882 (Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04977882 early_phase1completednot on this map

Abdominal Drainage, Postoperative Antibiotico-prophylaxis and CME With D3 Lyphadenectomy Effect on Gastrointestinal Function in Laparoscopic Right Hemicolectomy With Intracorporeal Anastomosis for Right Colon Cancer

TypeinterventionalSponsorUniversity of Rome Tor VergataRan2020 to 2023Enrolled36ConditionsColon CancerArmsabdominal drainage, Postoperative antibiotico-prophylaxis, Laparoscopic radical right colectomy with CME and D3 lymphadenectomy (RRC), Laparoscopic standard D2 right hemicolectomy (STANDARD)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Giuseppe S SicaDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Leandro SiragusaDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy. leandros93@hotmail.it.
Brunella Maria PirozziDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Roberto SorgeDepartment of Biostatistics, University of Rome "Tor Vergata", Rome, Italy.
Giorgia BaldiniDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Cristina FioraniDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Andrea Martina GuidaDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Vittoria BellatoDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.
Marzia FranceschilliDepartment of Surgical Sciences, University of Rome "Tor Vergata", Viale Oxford 81, 00133, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRoutine use of abdominal drain or prolonged antibiotic prophylaxis is no longer part of current clinical practice in colorectal surgery. Nevertheless, in patients undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis (ICA), it may reduce perioperative abdominal contamination. Furthermore, in cancer patients, prolonged surgery with extensive dissection such as central vascular ligation and complete mesocolon excision with D3 lymphadenectomy (altogether radical right colectomy RRC) is called responsible for affecting postoperative ileus. The aim was to evaluate postoperative resumption of gastrointestinal functions in patients undergoing right hemicolectomy for cancer with ICA and standard D2 dissection or RRC, with or without abdominal drain and prolonged antibiotic prophylaxis.

methodsMonocentric factorial parallel arm randomized pilot trial including all consecutive patients undergoing laparoscopic right hemicolectomy and ICA for cancer, in 20 months. Patients were randomized on a 1:1:1 ratio to receive abdominal drain, prolonged antibiotic prophylaxis or neither (I level), and 1:1 to receive RRC or D2 colectomy (II level). Patients were not blinded. The primary aim was the resumption of gastrointestinal functions (time to first gas and stool, time to tolerated fluids and food). Secondary aims were length of stay and complications' rate. CLINICALTRIALS: gov no. NCT04977882.

resultsFifty-seven patients were screened; according to sample size, 36 were randomized, 12 for each arm for postoperative management, and 18 for each arm according to surgical techniques. A difference in time to solid diet favored the group without drain or antibiotic independently from standard or RRC. Furthermore, when patients were divided with respect to surgical technique and into matched cohorts, no differences were seen for primary and secondary outcomes.

conclusionAbdominal drainage and prolonged antibiotic prophylaxis in patients undergoing right hemicolectomy for cancer with ICA seem to negatively affect the resumption of a solid diet after laparoscopic right hemicolectomy with ICA for cancer. RRC does not seem to influence gastrointestinal function recovery.

Indexed as

Anastomosis, SurgicalAntibiotic ProphylaxisColectomyDrainageLaparoscopyLymph Node ExcisionAgedFemaleGastrointestinal TractHumansMaleMiddle AgedPilot ProjectsAnastomosisColectomyColonic neoplasmsIleusMesocolon

Identifiers

PMID38970713
PMCPMC11227461

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.