Evidence map›Paper›PMID 32612345›Full record

Observational studyJSLS : Journal of the Society of Laparoendoscopic Surgeons

Operative Gynecological Laparoscopy Under Conscious Sedation.

Maurizio Rosati, Silvia Bramante, Fiorella Conti, Antonella Frattari, Maria Rizzi, Robert A Roman

Registry-linked trialOpen access · hybridAbstract readCase ReportsObservational Study
In one paragraph

Observational study in JSLS : Journal of the Society of Laparoendoscopic Surgeons. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06875791 (A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
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.

NCT06875791 phase1 / phase2not yet recruitingnot on this map

A Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Patients Undergoing Treatment for Head and Neck Cancer

TypeinterventionalSponsorFundacion Clinica Valle del LiliRan2025 to 2026Enrolled40ConditionsSquamous Cell Carcinoma of the Head and Neck, Oral MucositisArmsGreen Tea Extract with Morphine, Active Comparator: Triple Mixture Oral Rinse for Radiation-Induced Mucositis
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

6 authors at 2 institutions in 2 countries.

Maurizio RosatiUnit of Obstetrics and Gynecology, Santo Spirito Hospital, Pescara, Italy.
Silvia BramanteUnit of Obstetrics and Gynecology, Santo Spirito Hospital, Pescara, Italy.
Fiorella ContiUnit of Obstetrics and Gynecology, Santo Spirito Hospital, Pescara, Italy.
Antonella FrattariUnit of Anaesthesia and Intensive Care, Santo Spirito Hospital, Pescara, Italy.
Maria RizziUnit of Anaesthesia and Intensive Care, Santo Spirito Hospital, Pescara, Italy.
Robert A RomanCamran Nezhat Institute, Palo Alto, CA, USA.
Ospedale di Santo Spirito · ITCenter for Special Minimally Invasive and Robotic Surgery · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesOperative laparoscopy is generally performed under general anesthesia. Local anesthesia and conscious sedation may be useful in select short procedures. In the present study, we evaluated safety and efficacy of operative laparoscopy under conscious sedation.

methodsRetrospective observational study evaluating patients undergoing gynecologic laparoscopy. Laparoscopy under conscious sedation was performed for each patient with umbilical direct insertion of a 12-mm port, followed by 2 ancillary ports at 1 cm medially to the anterior superior iliac spine. Conversion to conventional laparoscopy or laparotomy was recorded. Conscious sedation was obtained using Remifentanil and Propofol, administered by an infusion system based on pharmacokinetic and pharmacodynamic models. Local anesthesia was administered at port insertion sites and for paracervical block. Pain intensity was evaluated with the Visual Analog Scale (VAS). Adverse events and drug concentrations throughout the procedure were retrieved.

resultsOur study population included 166 patients. They underwent laparoscopic unilateral versus bilateral salpingo-oophorectomy, ovarian cystectomy, bilateral salpingo-oophorectomy and omentectomy for a borderline ovarian tumor, myomectomy; or underwent surgery for unexplained infertility evaluation, pelvic pain, staging of ovarian cancer. Mean duration of pneumoperitoneum was 22.3 ± 7.2 min. Rate of conversion to laparoscopy under general anesthesia was 17/166 (10.2%) and there were only 3 cases of patients with low tolerability to the procedure. No severe adverse events occurred. Hospital discharge occurred in all unconverted cases after 6 to 18 h.

conclusionsOperative laparoscopy under conscious sedation and local anesthesia appears to be a feasible technique in gynecologic surgery with no adverse patient outcomes.

Indexed as

AdultAgedAnesthesia, ObstetricalFemaleGynecologic Surgical ProceduresHumansLaparoscopyMiddle AgedProcedural SedationRetrospective StudiesConscious sedationLaparoscopyMinimally invasive surgery

Identifiers

PMID32612345
PMCPMC7316526
OpenAlexW3040147792

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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.