Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Markus W Büchler


Contact details

University of Heidelberg Medical School
Im Neuenheimer Feld 110
+49 6221 56 6200

Additional identifiers

EudraCT number number

Protocol/serial number

KSC 02/2003

Study information

Scientific title

Clips versus Ligatures in Thyroid Surgery: a randomised controlled trial



Study hypothesis

To date, no clear scientific recommendation exists in regard to the available blood vessel ligation techniques in thyroid surgery. A systematic review comparing different blood vessel ligation techniques has not yet been performed. The literature on this topic shows several deficits thus reducing its internal and external validity. Main problems are underpowered sample sizes, missing data in regard to the surgical technique, lack of standardization of the various surgical techniques and of homogeneity of the used study designs.

Therefore a randomized controlled multicenter, patient-blinded, two-group parallel relevance study under standardized conditions is required in order to achieve high internal as well as external validity. This would allow the results to be generalized for thyroid surgery and also may have implications for other surgical settings. This study is one of the first studies designed and organized by the Study Center of the German Surgical Society (SDGC). Besides investigating the primary hypothesis, this study was also started with the aim of developing a nationwide structure for randomized trials using a common and surgical relevant procedure.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Thyroid surgery


The standard surgical approach in both treatment groups will be the Dunhill-Procedure which consists of a hemithyroidectomy and a subtotal thyroidectomy (at least 2/3 of the gland). The randomisation will proceed when the thyroid gland has been exposed and the decision in favour of a Dunhill procedure is made. Initially the vessels of the upper pole of the thyroid (hemithyroidectomy side) are localised and dissected from medial. Afterwards they are ligated with the conventional clamp-tie technique (Novafil 3-0 or equivalent monofilament suture type). Time is measured from ligating the vessels of the upper pole to the removal of the complete specimen. All vessels except the upper pole vessels of both sides are ligated according to the randomised technique: either using the clip vessel ligation technique or occluding manually by single ligatures (Vicryl 3-0).

Intervention type



Not Specified

Drug names

Primary outcome measure

The primary objective of this study is to test whether there is a relevant reduction in operating time (>15 min), using the clip vessel occluding technique versus the conventional clamp-tie.

Secondary outcome measures

Secondary objectives are divided into surgical and non-surgical categories. In the surgical category there are the following points: total duration of operation (skin incision until suture), weight of specimen, amount of postoperative bleeding, frequency of reoperation due to bleeding, recurrent laryngeal nerve paralysis (temporary or irreversible – pre- and postoperative assessment of vocal cord function by ENT-specialist), wound infection rate and rate of impaired parathyroid gland function. The non-surgical category consists of duration of postoperative hospital stay.

To assess the relevance of the chosen endpoints, the following ten aspects have to be ranked from "most important" to "least important" by patients and surgeons (only once): Intraoperative complications, postoperative complications, length of hospital stay, voice function, dysphagia, death, postoperative pain, postoperative fatigue, convalescence of complete physical maximum resilience and cosmetic result.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

The trial population consists of hospitalised patients of the four participating Departments of Surgery, who are planned for an elective thyroid operation. These operations can be performed with either the clip vessel ligation technique or the conventional clamp-tie technique.

At study enrollment:
• Age equal or greater than 18 years
• Expected survival time more than 12 months
• Patients with benign diseases of the thyroid gland scheduled for elective surgery
• Euthyroid metabolism (normal level of TSH or T3/T4)
• Normal function of the vocal cords
• Informed consent

At the end of surgical exploration:
• Suitable for at least 2/3 resection of the thyroid

Participant type


Age group




Target number of participants


Participant exclusion criteria

Malignant disease or high suspicion for malignancy (clinical and imaging evidence)
Nerve palsy
Graves' Disease
Current immunosuppressive therapy
Chemotherapy within 2 weeks before operation
Radiotherapy completed no longer than 8 weeks before operation
Severe psychiatric or neurologic disease
Drug- and/or alcohol-abuse
Participation in another intervention-trial with interference of intervention and outcome
Inability to follow the instructions given by the investigator or the telephone interviewer
Lack of compliance

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Heidelberg Medical School

Sponsor information


University of Heidelberg Medical School (Germany)

Sponsor details

Im Neuenheimer Feld 110
+49 6221 56 6200

Sponsor type




Funder type


Funder name

Grant from the German Ministry of Research and Education and supported by the BBD-Aesculap© Company, Tuttlingen, Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2006 protocol in:
2. 2012 results in:

Publication citations

  1. Protocol

    Seiler CM, Fröhlich BE, Veit JA, Gazyakan E, Wente MN, Wollermann C, Deckert A, Witte S, Victor N, Buchler MW, Knaebel HP, Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery., Trials, 2006, 7, 27, doi: 10.1186/1745-6215-7-27.

  2. Results

    Diener MK, Seiler CM, von Frankenberg M, Rendel K, Schüle S, Maschuw K, Riedl S, Rückert JC, Eckmann C, Scharlau U, Ulrich A, Bruckner T, Knaebel HP, Rothmund M, Büchler MW, , Vascular clips versus ligatures in thyroid surgery--results of a multicenter randomized controlled trial (CLIVIT Trial)., Langenbecks Arch Surg, 2012, 397, 7, 1117-1126, doi: 10.1007/s00423-012-0976-y.

Additional files

Editorial Notes

02/10/2017: internal review.