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Comparison of "Pick'n Roll" Single-incision Laparoscopic Cholecystectomy Technique, and Laparoscopic Cholecystectomy

28 de maio de 2014 atualizado por: Recep Aktimur, Samsun Education and Research Hospital

Prospective Randomized Comparative Study of New Single-incision Laparoscopic Cholecystectomy Technique, "Pick'n Roll", Versus Conventional Four-port Laparoscopic Cholecystectomy

Cholecystectomy is one of the most common operation performed by general surgeons. Since, first video-laparoscopic cholecystectomy in 1987, laparoscopic cholecystectomy (LC) has become the gold standard treatment for benign biliary disease. In daily practice, LC has increased general surgeons familiarity to video-laparoscopic operations and has become the first step to search more minimally invasive techniques and to perform advanced laparoscopic operations. In order to move forward the minimal invasive surgery concept with less surgical trauma and better cosmetic results, surgeons firstly reduced the number of incision and ports, then the idea of totally eliminating skin incisions through the use of natural orifices was implemented in selected cases.

In theory, minimal incision must provide minimal postoperative pain and better cosmetic results. With the use of single-incision laparoscopic cholecystectomy (SILC), this purpose is achieved by means of cosmesis but providing minimal postoperative pain is still controversial. Recent reports on, LC vs. SILC showed significantly favorable cosmetic benefit, comparable complication rate and hospital stay with SILC, but the mean operation time was significantly longer. Today, lack of standardized operation technique, the need for specialized instruments, the fear of inability to apply safe cholecystectomy principles, longer operation time, cost-effectivity and advanced laparoscopic experience are still limiting factor to performing SILC.

The aim of this prospective randomized controlled trial is to compare gold standard LC and SILC using our new technique called "Pick'n roll" (SILC-PR). Our goal was to provide critical view of safety and safe cholecystectomy principles on SILC, improve operator ergonomics and shorten operation time while eliminating the need for specialized instruments.

Visão geral do estudo

Descrição detalhada

A pilot study was conducted, with ten patients who were planned to perform laparoscopic cholecystectomy after approval by the ethics committee of Ondokuz Mayis University, Samsun, Turkey. Among ten patients, five patients were undergone LC, and another five were undergone SILC-PR.

The sample size was calculated from the pilot study. Simple consecutive allocation method was used to randomly divide the subjects into LC (classical four port technique), and SILC-"Pick'n roll" (PR) beginning and experienced groups. Each group contained 20 patients. The randomization was achieved regardless of demographic characteristics, by Dr. N. O.

One surgeon was performed all operation (Dr. R. A.). Patient's data were recorded by Dr. K. Y. At the end of the study, the data were analysed by Dr. S. C. and Dr. E. C. in a blinded manner to avoid bias

Surgical Procedures The technique used for LC was the conventional four-trocar approach (10-mm optic at the umbilicus, 10-mm trocar in the epigastrium and two 5-mm trocars in the right upper abdomen).

For SILC-PR, the patient was positioned supine on the operating table, once the access is gained into the abdomen, the patient re-positioned to reverse trendelenburg and left tilt. The surgeon stands on the left side of the patient and the assistant stands opposite him during the placement of the single-port device. SILC-PR was performed by the single-incision, single port technique using The OCTOTMPort (Dalimsurg, Seoul, Korea). The OCTOTMPort is a re-usable single-port device that contains two 5-mm, one 10-mm and one 12-mm port through the same port. Surgical access to the abdomen was obtained through an intraumbilical 2.5 cm incision from 12 o'clock to 6 o'clock. The OCTOTMPort was inserted and pneumoperitoneum was created up to an abdominal pressure of 15 mmHg. A 10-mm, 30º traditional scope (Karl Storz, Tuttlingen, Germany) was inserted through inferior placed 10-mm port, by the assistant who positioned on the patient's left side, and the peritoneal cavity was examined. If the stomach was distended, a nasogastric tube insertion was requested from the anesthesiologist. The surgeon introduced an Endo Grasp™ (Covidien, Mansfield, MA, USA) with left hand and elevated gallbladder fundus to assess the mobility of the gallbladder infindibulum, constant fundus retraction was used in whole operation by this instrument. In the presence of omental attachments, the gallbladder infindibulum was freed with monopolar hook device which holding by the surgeon's right hand, under the traction of the fundus. Once the gallbladder infindibulum freed from the attachments or clearly seen in first examination next step of the operation was launched. A 2.0 multifilament straight atraumatic needle was inserted through the surgeon's left of the falciform ligament with simultaneous palpation of the abdominal wall for optimum insertion site. The needle was grasped with a laparoscopic needleholder using by surgeon's right hand, and the needle was passed through the Hartmann's pouch at the lowest accessible point. To allow infindibulum retraction, wide triangulation and free Hartmann's pouch manipulation like "puppeteer movement", the passing suture with needle was turned around the afferent suture and a "half-knot" was created. The needle was passed back of the abdomen from the surgeon's left of the midclavicular line, with simultaneous palpation of the abdominal wall for optimum site. After this point, an assistant or a nurse was grasped two ends of the suspensory suture with clamps. With the help of fundus retraction and assistant's right or left hand dominant pulling tension on the suture, classical Hartmann's pouch retraction similar to LC technique was provided. Dissection of Calot's triangle and removal of gallbladder from the liver bed are possible in almost all cases with the use of aforementioned "Pick'n roll technique" and a hook diathermy.

Tipo de estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Samsun, Peru, 55200
        • Samsun Education and Research Hospital, Department of General Surgery, Samsun, Turkey

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Symptomatic cholelithiasis

Exclusion Criteria:

  • Acute cholecystitis (diagnosed on ultrasound or elevated inflammatory serum markers)
  • Choledocholithiasis
  • Less than 18 years old
  • American Society of Anesthesiologist (ASA) grade IV or V.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Four port laparoscopic cholecystectomy
This group of patients undergone classical four port laparoscopic cholecystectomy
Classical four port laparoscopic cholecystectomy
Comparador Ativo: SILC-Pick'n roll-Beginning (group I)
This group of patients undergone single-incision laparoscopic cholecystectomy using our new technique called "Pick'n roll", this group was designed new intervention's beginning arm.
SILC-PR was performed by the intraumbilical single port technique. A 10-mm, 30º scope was used. The surgeon was elevated gallbladder fundus with left hand using grasper in whole operation. If required, infindibulum was freed with monopolar hook. A 2.0 straight needle was inserted through the right of the falciform ligament, grasped with a laparoscopic needleholder using by surgeon's right hand, and passed through the Hartmann's pouch at the lowest point. To allow free manipulation, the passing suture with needle was turned around the suture to form a "half-knot". The needle was passed back out from the right of the midclavicular line. An assistant was grasped two ends of the suture and with the help of right or left hand dominant pulling tension, critical view of safety was provided
Comparador Ativo: SILC-Pick'n roll-Experienced (group II)
This group of patients undergone single-incision laparoscopic cholecystectomy using our new technique called "Pick'n roll", this group was designed new intervention's experienced arm.
Similar technique of SILC-Pick'n roll-Beginning (group I) was used

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Operation time
Prazo: Up to 1.5 hours
Up to 1.5 hours

Medidas de resultados secundários

Medida de resultado
Prazo
Conversion to open or classical laparoscopic cholecystectomy
Prazo: Up to 1.5 hours
Up to 1.5 hours
Insertion of additional port/ports.
Prazo: Up to 1.5 hours
Up to 1.5 hours
Intraoperative complication
Prazo: Up to 1.5 hours
Up to 1.5 hours
Lenght of hospital stay
Prazo: Up to 3 days
Up to 3 days
Postoperative complication rate
Prazo: Up to 1 month
Up to 1 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Recep Aktimur, Samsun Education and Research Hospital, Samsun, Turkey

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Real)

1 de abril de 2014

Conclusão do estudo (Real)

1 de abril de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2014

Primeira postagem (Estimativa)

29 de maio de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

29 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2014

Última verificação

1 de maio de 2014

Mais Informações

Termos relacionados a este estudo

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